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Proton Beam Therapy

MRI-Guided Prostate Boosts for Prostate Cancer (BLaStM Trial)

N/A

Recruiting

Led By Alan Pollack, MD, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gleason score 6-10

No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5.25 years (post-treatment)

Awards & highlights

BLaStM Trial Summary

This trial is testing a new, more effective radiation treatment for prostate cancer. The hope is that it will improve cancer control and quality of life by reducing damage to nearby organs.

Who is the study for?

Men aged 35-85 with confirmed prostate cancer (adenocarcinoma), T1-T3 stage, Gleason score 6-10, and PSA ≤100 ng/mL. No metastasis or previous radical prostate surgery/radiotherapy. Androgen deprivation therapy is allowed if decided before joining. Participants must be able to consent and willing to complete quality of life assessments.Check my eligibility

What is being tested?

The study tests adding a high dose radiation treatment targeting MRI-defined high-risk tumor areas in the prostate, on top of standard radiation therapy, aiming to control cancer while sparing nearby organs from excess radiation.See study design

What are the potential side effects?

Potential side effects may include discomfort at the treatment site, fatigue, urinary issues like increased frequency or urgency, bowel changes such as diarrhea or rectal bleeding, and sexual dysfunction.

BLaStM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has a Gleason score between 6 and 10.

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I have not had a complete prostate removal surgery.

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I am between 35 and 85 years old.

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My prostate cancer is confirmed by biopsy.

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My cancer is in an early to mid-stage according to a physical exam.

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My cancer has not spread to other parts of my body according to tests.

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I can take care of myself but might not be able to do heavy physical work.

BLaStM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5.25 years (post-treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5.25 years (post-treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5.25 years (post-treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Early Prostate Tumor Response (EPTR)

Secondary outcome measures

Change in CTC Levels

Change in gene/biomarker expression

Correlation between EPTR and Changes in serial post-RT MRIs

+5 more

BLaStM Trial Design

2Treatment groups

Experimental Treatment

Group I: LEAD RT GroupExperimental Treatment1 Intervention

Participants in this group will receive the Lattice Extreme Ablative Dose (LEAD) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 8 weeks.

Group II: HEIGHT RT GroupExperimental Treatment1 Intervention

Participants in this group will receive the Hypofractionated Extended Image-Guided Highly Targeted (HEIGHT) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 7 and a half weeks.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

900 Previous Clinical Trials

409,768 Total Patients Enrolled

16 Trials studying Prostate Cancer

3,723 Patients Enrolled for Prostate Cancer

Alan Pollack, MD, PhD5.02 ReviewsPrincipal Investigator - University of Miami

University of Miami

5 Previous Clinical Trials

2,435 Total Patients Enrolled

5 Trials studying Prostate Cancer

2,435 Patients Enrolled for Prostate Cancer

5Patient Review

Dr. Pollack is a highly skilled researcher who will go above and beyond to ensure your needs are met. He's compassionate and competent — a rare find in the medical field today.

Media Library

HEIGHT RT (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02307058 — N/A

Prostate Cancer Research Study Groups: LEAD RT Group, HEIGHT RT Group

Prostate Cancer Clinical Trial 2023: HEIGHT RT Highlights & Side Effects. Trial Name: NCT02307058 — N/A

HEIGHT RT (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02307058 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current maximum capacity for enrollment in this clinical trial?

"Affirmative. Per the clinicaltrials.gov page, this research study is actively accepting participants from one site with a total of 164 required individuals since February 5th 2015 when it was initially advertised and last amended on May 23rd 2022."

Answered by AI

Is submission of applications to participate in this study still feasible?

"Affirmative. Clinicaltrials.gov records suggest that this clinical trial, initially posted on February 5th 2015, is currently looking for volunteers; 164 participants are needed from a single medical centre."

Answered by AI

Am I eligible to participate in this investigation?

"This research project is enrolling 164 individuals with prostate cancer aged 35 and 85. To qualify, they must have a Gleason score between 6-10, start their treatment no later than 3 months before signing the consent form, initiate the therapy prior to beginning radiotherapy therapies, and complete the program within 30 months total."

Answered by AI